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entitled 'Food and Drug Administration: Better Coordination Could
Enhance Efforts to Address Economic Adulteration and Protect the
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United States Government Accountability Office:
GAO:
Report to Congressional Requesters:
October 2011:
Food and Drug Administration:
Better Coordination Could Enhance Efforts to Address Economic
Adulteration and Protect the Public Health:
GAO-12-46:
GAO Highlights:
Highlights of GAO-12-46, a report to congressional requesters.
Why GAO Did This Study:
In recent years, the United States experienced public health crises
suspected to have been caused by the deliberate substitution or
addition of harmful ingredients in food and drugs—specifically
melamine in pet food and oversulfated chondroitin sulfate in the blood
thinner heparin. These ingredients were evidently added to increase
the apparent value of these products or reduce their production costs,
an activity GAO refers to as economic adulteration. The Food and Drug
Administration (FDA), an agency within the Department of Health and
Human Services (HHS), has responsibility for protecting public health
by ensuring the safety of a wide range of products that are vulnerable
to economic adulteration. This report examines (1) the approaches that
FDA uses to detect and prevent economic adulteration of food and
medical products and (2) the challenges FDA faces in detecting and
preventing economic adulteration and views of stakeholders on options
for FDA to enhance its efforts to address economic adulteration. GAO
reviewed FDA documents and interviewed FDA officials and stakeholders
from academia and industry, among others.
What GAO Found:
FDA primarily approaches economic adulteration as part of its broader
efforts to combat adulteration in general, such as efforts to ensure
the safety of imported products. Agency officials noted that the
Federal Food, Drug, and Cosmetic Act does not distinguish among
motives or require motive to be established to determine whether a
product is adulterated. However, a senior FDA official told GAO that
there is value in making a distinction between economic adulteration
and other forms of adulteration to guide the agency’s thinking about
how to be more proactive in addressing this issue. An FDA official
told GAO when the agency detects any form of adulteration that poses
an adverse public health effect, it can conduct an investigation,
request a recall to get the product off the market, and take
enforcement action. In addition to these broader efforts, some FDA
entities also have undertaken efforts that specifically focus on
economic adulteration. For example, FDA’s Office of Regulatory Affairs
has contracted with a research center to model risk factors for
improved detection of economic adulteration of food. However, FDA
entities have not always communicated or coordinated their economic
adulteration efforts. For example, FDA’s Center for Veterinary
Medicine was unaware of and did not participate in two other entities’
economic adulteration efforts involving products the veterinary center
regulates. In another instance, two FDA entities engaged in similar
efforts but did not communicate or coordinate them, even though
officials said such communication might be beneficial. Furthermore,
FDA has not issued specific written guidance on how its centers and
offices should approach or address their economic adulteration
efforts. This is not consistent with federal standards for internal
control, which require agencies to have documented policies and
procedures.
FDA officials and stakeholders GAO interviewed cited several key
challenges to detecting and preventing economic adulteration,
including increased globalization and lack of information from
industry. Globalization has led to an increase in the variety,
complexity, and volume of imported food and drugs, which complicates FDA
’s task of ensuring their safety. In addition to globalization, an
increase in supply chain complexity—the growth in the networks of
handlers, suppliers, and middlemen—also complicates FDA’s task, making
it difficult to trace an ingredient back to its source. FDA officials
and stakeholders also said that gathering information from industry,
such as information on potentially adulterated ingredients, presents
challenges for FDA in detecting and preventing economic adulteration
due to industry’s reluctance to share such information because it is
proprietary. Stakeholders cited greater oversight and information
sharing as options to improve FDA’s ability to combat economic
adulteration. Specifically, some stakeholders supported increased
oversight, such as the use of technology to trace adulterated
ingredients back to the point of contamination, as an option to obtain
more information on supply chains. Many stakeholders also suggested
that FDA increase its regulatory and enforcement actions to address
economic adulteration, including in instances that may not have a
large negative public health impact. Stakeholders also suggested that
greater communication with industry, through such means as an
information clearinghouse or more informal interactions, could enhance
FDA efforts to gather information on economic adulteration.
What GAO Recommends:
GAO recommends that FDA adopt a working definition of economic
adulteration, enhance communication and coordination of agency
efforts, and provide guidance to agency centers and offices on the
means of addressing economic adulteration. HHS neither agreed nor
disagreed with GAO’s recommendations, but cited planned actions
related to adopting a definition and enhancing communication and
coordination.
View [hyperlink, http://www.gao.gov/products/GAO-12-46] or key
components. For more information, contact Lisa Shames at (202) 512-
3841 or shamesl@gao.gov, or Marcia Crosse at (202) 512-7114 or
crossem@gao.gov.
[End of section]
Contents:
Letter:
Background:
FDA Has Many Efforts to Address Economic Adulteration but Has Missed
Opportunities to Communicate and Coordinate:
FDA Faces Challenges in Addressing Economic Adulteration, and
Stakeholders Identified Options That May Help Agency Efforts:
Conclusions:
Recommendations for Executive Action:
Agency Comments and Our Evaluation:
Appendix I: Objectives, Scope, and Methodology:
Appendix II: Comments from the Department of Health and Human Services:
Appendix III: GAO Contacts and Staff Acknowledgments:
Related GAO Products:
Figure:
Figure 1: Illustrative Supply Chain for Canned Tuna:
Abbreviations:
API: active pharmaceutical ingredient:
CBER: Center for Biologics Evaluation and Research:
CDER: Center for Drug Evaluation and Research:
CDRH: Center for Devices and Radiological Health:
CFSAN: Center for Food Safety and Applied Nutrition:
CVM: Center for Veterinary Medicine:
FDA: Food and Drug Administration:
HHS: Department of Health and Human Services:
ORA: Office of Regulatory Affairs:
PREDICT: Predictive Risk-based Evaluation for Dynamic Import
Compliance Targeting:
USP: United States Pharmacopeia:
[End of section]
United States Government Accountability Office:
Washington, DC 20548:
October 24, 2011:
The Honorable Henry A. Waxman:
Ranking Member:
Committee on Energy and Commerce:
House of Representatives:
The Honorable Frank Pallone, Jr.
Ranking Member:
Subcommittee on Health:
Committee on Energy and Commerce:
House of Representatives:
The Honorable John D. Dingell:
House of Representatives:
In recent years, the United States experienced two crises suspected to
have been caused by the deliberate substitution or addition of harmful
ingredients in food and drugs. These ingredients were evidently added
to increase the apparent value of these products or reduce their
production costs, an activity we refer to as "economic adulteration."
Specifically, in 2007, vegetable protein products imported to the
United States from China were found to contain melamine, an industrial
chemical, which later investigation suggested had been added to give
the appearance of higher protein content. The products were used as
ingredients in pet food, sickening and killing an unknown number of
dogs and cats.[Footnote 1] In 2008, heparin--a commonly used blood
thinner--was imported from China and found to contain oversulfated
chondroitin sulfate, a toxic contaminant that mimics heparin. The
contaminated heparin was linked to a number of serious allergic
reactions and deaths in the United States. In addition to harming
public health, such incidents can undermine confidence in the safety
of the nation's food and medical products and have significant
economic consequences for industry. For example, the melamine incident
prompted pet food manufacturers to recall over 150 brands of dog and
cat food across the United States, and the heparin crisis prompted 16
drug and device firms to recall at least 11 drug products and 72
heparin-containing medical devices.
The Food and Drug Administration (FDA), an agency within the
Department of Health and Human Services (HHS), has responsibility for
protecting public health by ensuring the safety of a wide range of
food and medical products (drugs, medical devices, and
biologics[Footnote 2]) that are vulnerable to, among other things,
economic adulteration. With increasing globalization of food
production and medical product manufacturing, the volume of imported
goods regulated by FDA has more than doubled in the last decade. As a
result, according to FDA documents, from 10 to 15 percent of all food
consumed in the United States is now imported, as are about 80 percent
of the active pharmaceutical ingredients in drugs, nearly 40 percent
of finished drugs, and half of all medical devices. FDA expects the
growth in imports to continue. The FDA Commissioner has said that
globalization presents huge and growing challenges and that economic
adulteration remains a public health threat. She indicated that
another public health crisis like heparin or melamine seems inevitable
unless FDA is able to forge changes in how it ensures the safety and
quality of food and medical products. In part due to regulatory
challenges posed by increased globalization, we included federal
oversight of both food and medical products in our 2011 list of
federal programs at high risk for waste, fraud, abuse, or
mismanagement that warrant attention by Congress and the executive
branch.[Footnote 3] We first added federal oversight of food safety to
our High-Risk list in January 2007 and federal oversight of medical
products in January 2009.[Footnote 4]
This report responds to your request that we review how FDA oversees
the safety of food and drugs in order to prevent and respond to
economic adulteration. This report examines (1) the approaches that
FDA uses to detect and prevent economic adulteration of food and
medical products and (2) the challenges, if any, FDA faces in
detecting and preventing economic adulteration and stakeholder views
on options for FDA to enhance its efforts to address economic
adulteration.
For purposes of this report, we define economic adulteration as "the
fraudulent, intentional substitution or addition of a substance in a
product for the purpose of increasing the apparent value of the
product or reducing the cost of its production, i.e., for economic
gain. [It] includes dilution of products with increased quantities of
an already-present substance (e.g., increasing inactive ingredients of
a drug with a resulting reduction in strength of the finished product,
or watering down of juice) to the extent that such dilution poses a
known or possible health risk to consumers, as well as the addition or
substitution of substances in order to mask dilution." This definition
is the same as the working definition of "economically motivated
adulteration" that FDA developed for a May 2009 public meeting
[Footnote 5] to raise awareness and solicit input on the topic.
[Footnote 6]
To determine the approaches FDA uses to detect and prevent economic
adulteration, we interviewed FDA officials about the agency's efforts
to address economic adulteration and reviewed relevant FDA documents.
We also reviewed our previous reports on FDA's oversight of food and
medical products, as well as the agency's strategic planning efforts.
We compared FDA's efforts to address economic adulteration with
federal standards for internal control. To determine the challenges
FDA faces in detecting and preventing economic adulteration, we
interviewed FDA officials and stakeholders, including former FDA
officials and some representatives from academia, industry, and
consumer groups who made presentations at FDA's May 2009 meeting on
economically motivated adulteration. We also interviewed the
stakeholders to obtain their views on options for FDA to enhance its
efforts to address economic adulteration. The views of these
stakeholders are not representative of and cannot be generalized to
all stakeholders. Appendix I contains a detailed discussion of the
scope and methodology of our review.
We conducted this performance audit from September 2010 to October
2011 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
Background:
FDA is responsible for protecting public health by ensuring the safety
and efficacy of medical products marketed in the United States--
including drugs, medical devices, and biologics--and the safety of
nearly all food products other than meat and poultry,[Footnote 7]
regardless of whether they were manufactured domestically or overseas.
The agency's responsibilities for overseeing food and medical products
are divided among the following five FDA product centers, each
responsible for specific types of products:
* The Center for Biologics Evaluation and Research (CBER) is
responsible for regulating biologics for human use, such as blood,
blood products, vaccines, and allergenic products, and ensuring that
biologics are safe and effective.
* The Center for Devices and Radiological Health (CDRH) is responsible
for regulating firms that manufacture and import medical devices and
for ensuring that radiation-emitting products, such as lasers and x-
ray systems, meet radiation safety standards.
* The Center for Drug Evaluation and Research (CDER) is responsible
for regulating over-the-counter and prescription drugs for human use,
including generic drugs.
* The Center for Food Safety and Applied Nutrition (CFSAN) is
responsible for ensuring the safety of most foods for humans (except
meat and poultry and processed egg products, which are regulated by
the U.S. Department of Agriculture), including dietary supplements.
* The Center for Veterinary Medicine (CVM) is responsible for
regulating the manufacture and distribution of drugs, devices, and
food given to, or used by animals.
Among other things, the centers monitor the safety and effectiveness
of marketed medical products and the safety of food, formulate
regulations and guidance, conduct research, communicate information to
industry and the public, and set their respective program priorities.
In addition to the work of the five centers, FDA's Office of
Regulatory Affairs (ORA) conducts field work for the product centers
to promote compliance with agency requirements and applicable laws.
ORA field activities include inspecting domestic and foreign
manufacturing facilities, examining products offered for import,
collecting and analyzing samples, and taking enforcement action.
[Footnote 8] ORA's Office of Criminal Investigations is responsible
for investigating potential criminal violations involving FDA-
regulated products and may refer cases to the Department of Justice
for prosecution.
FDA's Office of the Commissioner is responsible for providing
leadership and direction to the product centers and ORA. FDA's Office
of International Programs is responsible for leading, managing, and
coordinating all of FDA's international activities and its recently
established overseas offices.
In July 2011, FDA created "directorates" that align similar functions
under common leadership within the Office of the Commissioner--the
Office of Medical Products and Tobacco, which oversees CBER, CDER, and
CDRH, as well as the Center for Tobacco Products; the previously
established Office of Foods, which oversees CFSAN and CVM; and the
Office of Global Regulatory Operations and Policy, which oversees ORA
and the Office of International Programs.
In recent years, we have reported on a variety of concerns related to
FDA's resource management, strategic planning, and internal
communications and coordination. Specifically, in June 2009, we found
that FDA was unable to provide complete and reliable estimates of its
resource needs for its medical products.[Footnote 9] In February 2010,
we reported on management challenges the agency faces and FDA's
difficulties in using practices for effective strategic and workforce
planning.[Footnote 10] Coordinating internally among its centers and
offices and externally with outside experts were among the agency's
major management challenges. Also, in September 2010, we reported on
FDA's overseas offices and the need for better coordination among the
centers.[Footnote 11] For a list of these and other related reports,
see Related GAO Products at the end of this report.
Federal Law on the Adulteration of FDA-Regulated Food and Medical
Products:
The Federal Food, Drug, and Cosmetic Act prohibits the introduction of
adulterated food, drugs, and medical devices into interstate commerce.
However, the act does not define or use the term "economic
adulteration" or "economically motivated adulteration." The act
includes, but is not limited to, the following:
* A food is deemed to be adulterated if, among other circumstances, it
bears or contains any added poisonous or deleterious substance that
may render it injurious to health. A food is also deemed to be
adulterated (1) if any valuable constituent has been omitted in whole
or in part, or (2) if any substance has been substituted wholly or in
part, or (3) if damage or inferiority has been concealed in any
manner, or (4) if any substance has been added so as to increase its
bulk or weight, or reduce its quality or strength, or make it appear
better or of greater value than it is.
* A drug is deemed to be adulterated if it purports to be a drug whose
name is recognized in an official compendium[Footnote 12] and its
strength differs from, or its quality or purity falls below, the
standards set forth in such compendium. If a drug does not purport to
be a drug listed in an official compendium, it is deemed to be
adulterated if its strength differs from, or its purity or quality
falls below, that which it purports to possess. A drug is also deemed
to be adulterated if, among other circumstances, any substance has
been (1) mixed or packed with it so as to reduce its quality or
strength or (2) substituted wholly or in part.
* A device is deemed to be adulterated if it is, or purports to be or
is represented as, a device which is subject to a performance standard
established or recognized under the act unless such device is in all
respects in conformity with such standard. It is also deemed
adulterated if, among other circumstances, the device was not
manufactured, packed, stored, or installed in conformity with good
manufacturing practices.
Economic Adulteration:
Economic adulteration is not a new problem and ranges from simple
actions, such as adding material to increase a product's weight, to
more sophisticated substitutions or additions that are designed to
avoid detection by tests known to be used to authenticate ingredients
or products. Economic adulteration differs from other forms of
intentional adulteration, such as bioterrorism or sabotage, whose
primary purpose is to cause harm. Because economic adulteration is
intentional, it also differs from unintentional adulteration, such as
adulteration through failure to follow good manufacturing practices.
Although the primary driver of economic adulteration is financial gain
rather than causing harm, it can pose a variety of public health
risks. The actual risks will vary depending on the adulterant used,
the person who consumes the product, and the length of use or
exposure. There is a direct and immediate threat to public health when
the adulterant is a toxic or lethal substance, as was the case in the
melamine and heparin incidents. There are also risks that arise as a
result of long-term, low-dosage exposure to a contaminant or as a
result of using a product whose nutritional value or efficacy has been
compromised by an adulterant. Certain populations, such as infants,
the elderly, and persons with compromised immune systems are
particularly vulnerable to these risks. In some cases, an adulterant
may only pose a public health risk for those who are allergic to it,
such as fish substituted with a less expensive fish to which a person
is allergic. Furthermore, economic adulteration that poses no known
health risk may expose a vulnerability in the supply chain--the
network of handlers, suppliers, and middlemen involved in the
production of food and drugs--that could be further exploited in the
future, with serious consequences.
Following the melamine and heparin incidents, FDA formed an internal
work group focused on predicting and addressing what the agency
referred to as "economically motivated adulteration." The work group,
comprising representatives from FDA's food and medical product centers
and ORA, held a May 2009 public meeting on the topic. For purposes of
the meeting, FDA developed a working definition of economically
motivated adulteration. The meeting, attended by representatives of
academia, industry, and consumer groups, was designed to raise
awareness about the potential for this problem and gather information
on how to better predict, prevent, and address it. According to FDA
officials, the work group stopped meeting shortly after the public
meeting was held. FDA made a transcript of the meeting publicly
available, but issued no report.
FDA Has Many Efforts to Address Economic Adulteration but Has Missed
Opportunities to Communicate and Coordinate:
FDA primarily approaches economic adulteration as part of its broader
efforts to detect and prevent adulteration of food and medical
products in general. In addition, CDER, ORA, CFSAN, and CBER have
undertaken efforts specific to economic adulteration, while CVM and
CDRH have not. However, agency entities have missed opportunities to
communicate and coordinate efforts specifically directed at economic
adulteration and identify potential public health risks.
FDA Primarily Approaches Adulteration Broadly, but Some Centers and
ORA Have Undertaken Efforts Specific to Economic Adulteration:
According to FDA officials, the agency primarily approaches economic
adulteration as part of its broader efforts to combat adulteration in
general. Such efforts include, for example, the agency's actions to
ensure the safety of imported products. According to FDA officials,
these broad efforts to combat adulteration could also combat economic
adulteration. Agency officials noted that the Federal Food, Drug, and
Cosmetic Act does not distinguish among motives or require motive to
be established to determine whether a product is adulterated. FDA
adopted a working definition of economically motivated adulteration
for the purposes of discussing the topic at its May 2009 public
meeting. In its written comments on our draft report, HHS told us that
the recently formed FDA Working Group on Economically Motivated
Adulteration will use the working definition proposed at the public
meeting, enabling FDA centers to focus their discussions and
encouraging communication and collaboration. According to an FDA
official, the agency generally does not expend resources to
distinguish between economic and other motives for adulteration.
Rather, when the agency detects any form of adulteration that poses an
adverse public health effect, it can conduct an investigation, request
a recall to get the product off the market, and take enforcement
action. A senior FDA official told us there is value in making a
distinction between economic adulteration and other forms of
adulteration to guide the agency's thinking about how to be more
proactive in addressing this issue.
Examples of broader FDA efforts to address adulteration include:
* ORA's Predictive Risk-Based Evaluation for Dynamic Import Compliance
Targeting (PREDICT). This tool generates a numerical risk score for
all FDA-regulated products by analyzing importers' shipment
information using sets of FDA-developed risk criteria based in part on
publicly available information,[Footnote 13] which may indicate
opportunities for economic adulteration. PREDICT then targets for
examination products that have a high risk score. As of September
2011, PREDICT was operating in ports of entry in 13 of 16 FDA
districts, and FDA officials said the agency expects PREDICT to be
operational in all ports of entry by the end of 2011.
* CVM's Pet Event Tracking Network (PETNet). In August 2011, CVM
launched PETNet, a secure, Internet-based network comprised of FDA and
other federal and state agencies with authority over pet food that
would allow them to exchange real-time information about outbreaks of
illness in animals associated with pet food and other pet food-related
incidents. PETNet members can elect to receive alerts about pet food
incidents and create alerts when they are aware of a pet food incident
within their jurisdiction. According to FDA, the information would be
used to help federal and state regulators determine how best to use
inspectional and other resources to either prevent or quickly limit
the adverse events caused by adulterated pet food. Use of the system
is voluntary.
* CDER's Secure Supply Chain Pilot Program. This program, which is in
the process of being implemented, is intended to help the agency
ensure the safety of imported drugs by enabling it to focus its
resources on preventing the importation of drugs that do not comply
with applicable FDA requirements. The program is intended to allow a
limited number of drug companies to import their products on an
expedited basis if, among other things, they can meet FDA criteria
showing that they maintain control over their products from
manufacture through entry into the United States. FDA expects to
announce the date on which it will begin accepting applications for
the pilot by the end of 2011.
In addition to these broader efforts, some FDA entities have
undertaken efforts specific to economic adulteration. For example, in
the aftermath of the melamine and heparin incidents, CDER, ORA, CFSAN,
and CBER have taken the following steps to specifically address
economic adulteration:
* CDER has developed a model to rank the 1,387 active pharmaceutical
ingredients (API) known to be in current use according to their
susceptibility to economic adulteration.[Footnote 14] According to
CDER officials, the ranking model incorporates various risk factors,
such as estimates for volume of use, cost per unit of the API, and
reliance on testing methods to check quality that are known to be less
accurate than more modern methods developed for other APIs. CDER
officials told us the center sampled and tested 20 of the 77 higher-
ranked APIs in 2010 and found no evidence of any significant
contamination suggesting intentional adulteration. According to agency
officials, after this pilot program is completed, FDA will determine
if the program was valuable and, if so, whether the model's risk
factors may need to be adjusted.
* CDER is leading efforts to work with United States Pharmacopeia
(USP) to focus on the vulnerability of drugs to economic adulteration.
USP is a nonprofit organization that sets standards for medicines,
food ingredients, and dietary supplements. USP's drug standards are
enforceable under the Federal Food, Drug, and Cosmetic Act. Actions
CDER officials say they have taken include selecting 20 USP
standards[Footnote 15] for updating that include certain over-the-
counter drugs, inactive ingredients used in high volume, and APIs that
use outdated technology or for which there are no procedures to
identify impurities. The goal of this modernization effort is to
replace outdated USP standards with more modern, accurate, and
specific ones. CDER has also worked closely with USP in revising the
heparin testing standard and the standards for glycerin and five other
similar drug product ingredients to prevent economic adulteration with
diethylene glycol, a cheaper, but deadly ingredient often substituted
for glycerin.
* ORA, along with the Department of Homeland Security and the
Department of Agriculture's Food Safety and Inspection Service,
contracted in 2010 with the University of Minnesota's National Center
for Food Protection and Defense to model risk factors for improved
detection of economic adulteration.[Footnote 16] The contract consists
of three phases: (1) a survey of U.S. companies to collect information
on prior or potential economic adulteration experiences and identify
characteristics of potential targets of economic adulteration; (2) the
development of strategies to group test methods to identify those
methods that pose the greatest potential risk for economic
adulteration, including the level of technical sophistication required
to exploit the test method; and (3) the development of supply chain
models in order to identify shifts in these supply chains that may
indicate the potential for economic adulteration.
* CFSAN formed a work group on the economic adulteration of food,
which started meeting in February 2008. CFSAN officials said the
group, which includes representatives from CVM and ORA, generally
meets monthly and is looking at the impact of economic adulteration on
food safety and whether there is other work that FDA could undertake
to mitigate that impact. Among other things, the group has proposed
creating a page on FDA's website on economic adulteration, and it has
developed a methodology for the testing of pomegranate juice, which
officials said they chose to focus on because it is expensive and
because its health benefits have been widely touted. CFSAN officials
said the group is also looking at ways to make industry more
comfortable with providing information to FDA on possible economic
adulteration.
* CFSAN has a number of efforts under way to develop analytical tests
and tools for detecting economic adulteration. For example, the center
has developed a method for analyzing nitrogen-containing compounds
similar to melamine that might be used to boost apparent nitrogen
content in milk and other protein products. CFSAN's research office
has a project to develop methods to detect the adulteration of
powdered milk products and fruit juices. One element of this project
involves the creation of a library of powdered milk signatures,
against which new samples can be compared (and adulterants identified)
using modern statistical methods. This project is slated for
completion over the next 2 years.
* CBER established a process in late 2008 to extract relevant product
component information from regulatory applications and input this data
into a database. The center has since expanded its process of
extracting product component information from applications to include,
for example, ingredients that may be subject to contamination. The
database includes nonproprietary, unique ingredient identifiers and
other information designed to facilitate faster identification of
products made from components suspected of being economically
adulterated.
In contrast to the other entities, senior CVM officials we spoke with
said that although the center has broad initiatives designed to
prevent and detect adulteration in general (i.e., PETNet), CVM has
undertaken no efforts targeted to economic adulteration and has no
plans to do so.[Footnote 17] Officials said that the melamine incident
gave them greater awareness that products with high-value ingredients
could be susceptible to economic adulteration and that this was the
only lesson they learned from the melamine incident. Officials said
they recognize that CVM-regulated products may be vulnerable to
economic adulteration because they are composed of numerous
byproducts, any one of which could be adulterated. Nevertheless, they
said that they do not believe economic adulteration is a growing
problem because of industry's overall awareness of its supply chain
through efforts such as verifying certificates of analysis of
ingredients from suppliers.
Officials from CDRH told us that, other than its broader efforts to
combat adulteration in general, the center had no initiatives
specifically directed at addressing economic adulteration, but
indicated they are responsible for products that are vulnerable to
economic adulteration. For example, CDRH officials said that they have
found that a manufacturer of imported sunglass lenses may have been
substituting inferior material. However, center officials were unaware
of any actual cases of economic adulteration involving products for
which they are responsible.
Agency Entities Have Not Communicated or Coordinated on Economic
Adulteration Efforts:
We found two instances in which CVM did not know about or participate
in efforts on economic adulteration that involved CVM-regulated
products. First, the director of the University of Minnesota's
National Center for Food Protection and Defense told us that, as part
of the center's contract with ORA, it will be drafting a list of foods
at high risk of economic adulteration and that the list will likely
include foods that are also used as animal feed ingredients. The
director noted that, with the exception of certain kinds of fats, the
global supply chain for animal food and feed is the same as that for
human foods. The director said that, for this reason, his center had
considered finding ways to make its work for FDA even more applicable
to animal feed. Although CVM provided developmental input, direction,
and technical support with regard to the contract, CVM officials said
they were not aware of the center's work under the contract to develop
this list of high-risk foods. Second, CFSAN has a research project
that focuses primarily on developing methods for authenticating
protein-based foods and ingredients, detecting the presence of
adulterants, and identifying chemical hazards in protein-based
products. Among other things, this project is to develop methods for
screening skim milk powder, which can be found in both food and animal
feed, for the presence of soy or other vegetable protein. Senior CVM
officials said they were unaware of this research project, but they
stated that CVM has been involved in developing methods to identify
contaminants of protein-based ingredients.
We also found an instance where FDA entities engaged in similar
efforts on economic adulteration but did not communicate or coordinate
about those efforts. Specifically, as we mentioned earlier, ORA and
CDER are engaged in similar efforts to determine which human foods and
drugs, respectively, are at greatest risk for economic adulteration.
However, according to ORA and CDER officials, they have not
coordinated those efforts or communicated about them, even though they
are using some of the same risk factors in their efforts--including
price fluctuations and reliance on less specific test methods.
Officials from both entities said that such communication and
coordination could be beneficial to both efforts.
In addition, we have previously identified internal coordination--
among FDA's centers and offices--as one of the agency's major
management challenges based on a review of evaluations of FDA by HHS
and the FDA Science Board, among others.[Footnote 18] Also, in our
2009 survey of FDA managers, 70 percent reported that better internal
coordination and communication would greatly improve their ability to
contribute to FDA's goals and responsibilities, though 28 percent
reported that FDA was making great progress in this area. Furthermore,
we asked FDA managers in our survey to identify the top priorities
that FDA leadership should address to achieve agency goals and
responsibilities, and the second most commonly identified issue was
improving coordination within FDA. In detailed written responses in
our survey, some managers noted that better coordination among FDA's
centers could increase effectiveness and decrease redundancy.
Furthermore, a recommendation made by FDA's work group on economic
adulteration in August 2009 related to communication--that FDA
designate a lead office and develop standard operating procedures for
information sharing--was not implemented. A senior FDA official told
us that there has been some work across FDA centers on economic
adulteration but that the centers did not see a lot of value in
additional coordination because of the differences between the
products each center oversees. However, the issue of economic
adulteration cuts across the agency, and without communicating about
and coordinating on economic adulteration efforts, FDA may not be
making the best use of scarce resources.
In August 2011, FDA officials told us that the agency's Compliance
Policy Council, which consists of senior representatives of ORA and
the FDA centers, met in July 2011 and discussed whether and how the
agency should coordinate work on economic adulteration. The council
directed risk management staff from ORA and the centers to form a
group to discuss opportunities to share intelligence and approaches to
economic adulteration and then report back to the council. According
to FDA officials, the proposed agenda included discussion about the
development of standard operating procedures. In its written comments
on our draft report, HHS told us that the work group held its first
meeting on September 23, 2011, while our report was at the agency for
comment.
The Commissioner and other senior FDA officials have often spoken
publicly about the threat posed by economic adulteration. In its July
2011 report entitled Pathway to Global Product Safety and Quality,
[Footnote 19] FDA stated that globalization has fundamentally altered
the economic and security landscape, requiring FDA to transform itself
into a global agency prepared to regulate in an environment in which
product safety and quality know no borders. The report also called
economically motivated harms perhaps the most serious challenge on the
horizon for the agency and noted that the heparin and melamine
incidents underscore how serious the potential danger can be. The
report also noted that FDA needs to move beyond its current efforts
and think strategically across the agency. However, FDA officials told
us that the Office of the Commissioner has not issued specific written
guidance on how FDA centers and offices should approach or address
their economic adulteration efforts. The Office of the Commissioner's
role is to provide policy making, program direction, coordination,
liaison, and expert advice for agency programs. According to federal
standards for internal control, agencies should have documented
policies and procedures in place to carry out management's directives.
[Footnote 20] This documentation should be readily available for
examination in management directives, administrative policies, or
operating manuals in paper or electronic form. In addition, the
federal standards call for effective communication, with information
flowing down, across, and up the organization.
FDA Faces Challenges in Addressing Economic Adulteration, and
Stakeholders Identified Options That May Help Agency Efforts:
FDA officials and stakeholders we interviewed cited several key
challenges the agency faces in detecting and preventing economic
adulteration, and stakeholders identified options for enhancing the
agency's efforts to address economic adulteration.
Key Challenges Include Increased Globalization and Lack of Information
from Industry:
FDA officials and stakeholders told us that responding to increased
globalization and the expanding complexity of the supply chains for
both food and medical products is a key challenge in addressing
economic adulteration. Globalization has led to an increase in the
variety, complexity, and volume of imported food and drugs, which
complicates FDA's task of ensuring their safety. In addition to
globalization, an increase in supply chain complexity--the growth in
the networks of handlers, suppliers, and middlemen--also complicates
FDA's task. According to FDA, the market for outsourcing portions of
pharmaceutical production has more than doubled in the past 9 years.
FDA noted in its July 2011 Pathway report that more products are
following increasingly complex paths through multi-step supply chains
before reaching the United States. Figure 1 illustrates the complex
supply chain of a single commodity, canned tuna. As the figure shows,
after the tuna is caught in East Asia, it can travel through many
countries for processing and canning before the finished product
finally reaches store shelves in the United States.
Figure 1: Illustrative Supply Chain for Canned Tuna:
[Refer to PDF for image: illustrated world map]
The map depicts example paths for the following:
Processed into frozen pieces;
Pre-canning processing;
Canning;
Distribution;
US consumption.
Source: FDA.
[End of figure]
FDA officials gave several reasons that this increasing complexity
poses a challenge. For example, CFSAN officials told us that food
companies can change ingredients and suppliers at will without having
to notify FDA of those changes, making it difficult to track or trace
an ingredient back to its source or supplier. However, many food
manufacturers are required to keep records of the immediate previous
sources of all foods received. Similarly, CDER officials said that it
is increasingly difficult to trace ingredients through drug supply
chains due to the increasing number of parties involved and the
increase in transfers between parties in other countries. Stakeholders
from associations representing the food and medical product industries
agreed that the large number of imported ingredients and foreign
establishments, as well as the difficulties related to tracking an
ingredient back to the original source, are of particular concern.
FDA officials and stakeholders said that obtaining information on
potential instances of economic adulteration is critical to addressing
the problem, but they also agreed that the agency faces challenges in
gathering such information from industry. Industry may be a source of
information on potential incidents of adulteration because companies
regularly test ingredients from suppliers. The responsible party for a
firm that introduces into commerce an article of food containing an
adulterated ingredient that could cause serious adverse health
consequences or death must report this information to FDA through the
Reportable Food Registry. However, agency officials and industry
representatives said industry is often reluctant to share such
information when an adulterated ingredient has not entered into
commerce. For example, a company may be concerned that it could
provoke a lawsuit if it reported a supplier for intentionally
adulterating products and the accusation was subsequently determined
to be unfounded. They said that a wrongful accusation can have serious
consequences, such as compromising the integrity of the company's
brands and products if certain information became public.
In addition to a need for more information about industry suppliers,
FDA officials told us that they need more information about substances
that could be used to adulterate products. These officials said that
new, more precise testing methods need to be developed to detect these
adulterants because some current tests are outdated or insufficiently
specific. Recent cases of melamine contamination in pet food
illustrate the need for such tests. The presence of melamine in pet
food was not initially discovered by the standard test for protein
because that test was designed to detect nitrogen and could not
distinguish between protein and melamine. The contamination was
ultimately discovered when FDA scientists developed a specific test to
identify melamine. FDA and others determined that melamine was
apparently selected as an adulterant to evade the original testing and
increase the apparent protein content.
CDER officials also told us that it is difficult to detect instances
of economic adulteration because the potential adulterant is often
unknown or has not yet been identified. For example, during the
heparin incident, the available test methods for heparin were not able
to detect the contaminant oversulfated chondroitin sulfate. FDA
collaborated with scientists outside the agency to identify the
contaminant and develop new tests to detect it. Industry may be the
best source of tests to detect adulteration because companies develop
such tests to monitor the products they receive from their suppliers;
however, industry officials indicated that they are often reluctant to
share such information because it is proprietary.
Stakeholders cited additional challenges that FDA faces in addressing
economic adulteration, including its legal authorities. For example,
one stakeholder said that FDA does not have the authority to accredit,
or approve third parties to inspect establishments that make drugs;
the stakeholder said that if FDA did have that authority, such
inspections may help decrease FDA's inspection workload and could
increase the total number of facilities inspected. FDA recently
received authority to recognize, in certain situations, accreditation
bodies that may then accredit qualified third parties to inspect food
establishments. The FDA Food Safety Modernization Act provides that,
no later than January 2013, FDA is to establish a program to recognize
these accreditation bodies. It is worth noting, though, that FDA has
had the authority to accredit third parties to conduct inspections of
certain domestic and foreign medical device manufacturing
establishments since 2002. FDA implemented its accreditation programs,
permitting eligible establishments to voluntarily request inspections
from third-party organizations, but relatively few establishments have
chosen to take advantage of this program.[Footnote 21]
Some stakeholders also told us that FDA's limited resources, including
staffing, present a challenge. Specifically, they said FDA has limited
ability to investigate potentially economically adulterated products
because such investigations are resource-intensive. They also told us
that FDA does not have the range of expertise among staff that is
needed to address economic adulteration, in particular staff with a
background in intelligence gathering or law enforcement. We have
previously reported on FDA's own concerns about its staffing levels
and oversight responsibilities for certain activities, such as its
oversight of medical devices and inspections of establishments that
manufacture approved drugs.[Footnote 22]
Some Stakeholders Cited Greater Oversight and Information Sharing as
Options to Address Economic Adulteration:
Some stakeholders supported increased oversight by FDA, in particular,
as an option to obtain more information on supply chains--information
that is useful in tracing the source of economic adulteration. For
example, one stakeholder suggested that the use of track-and-trace
technology--such as using standard numerical identifiers on
prescription drug packages--could facilitate FDA's oversight of the
supply chain by making it easier for FDA and industry to trace
adulterated ingredients back to the point of contamination. Under the
new FDA Food Safety Modernization Act, the Secretary of HHS, acting
through FDA, is directed to establish a system that will improve its
ability to rapidly track and trace both domestic and imported foods.
Similarly, the Food and Drug Administration Amendments Act of 2007
required FDA to develop a unique device identifier system to
adequately identify a medical device through distribution and use.
According to FDA officials, the agency expects to publish a proposed
rule on the establishment of this system by the end of 2011.[Footnote
23]
Many stakeholders also suggested that FDA increase its regulatory and
enforcement actions to address economic adulteration. These
stakeholders said that public health risk should be FDA's priority in
taking such actions, but many also told us that FDA should pursue
those who adulterate for economic gain, including in instances that
may not have a large negative public health impact. For example, some
stakeholders suggested building criminal cases against those who
adulterate for economic gain and prosecuting them swiftly and visibly
to help ensure that companies are complying with laws and regulations.
In addition, these stakeholders said that, even when the adulteration
has little health impact, such actions could help protect public
health by deterring future instances, some of which may pose a
significant health threat. Depending on the circumstances, such as the
type of violation and product involved, a range of enforcement actions
or penalties could be pursued. However, in February 2009, we reported
that FDA has taken few actions in pursuing instances of economic fraud
in seafood.[Footnote 24] In that report, we found that FDA did not
issue any regulatory letters to companies regarding seafood fraud from
2005 through 2008, and according to a senior FDA official, the agency
had not taken any enforcement actions for seafood fraud since 2000.
Even with the challenges related to the disclosure of proprietary
information, stakeholders also suggested that greater communication
with industry could enhance FDA efforts to gather information on
economic adulteration. One option for greater communication that
several stakeholders identified was the creation of an information
clearinghouse, through which companies could anonymously share
information on adulterated ingredients with FDA and other companies.
Stakeholders noted that the clearinghouse could enhance FDA's ability
to disseminate information on adulterated products quickly, facilitate
secure information sharing across industries, and enable FDA and
industry to respond more rapidly to potential instances of
adulteration. For example, they said that a clearinghouse could allow
the sharing of information, such as information on market price
fluctuations, environmental disasters, or other macroeconomic factors.
In the view of these stakeholders, this type of information may help
both industry and FDA better target their efforts to detect and
prevent economic adulteration. One stakeholder said that such a
clearinghouse was an opportunity for industry and FDA to share
information from various sources in a central location, which would
help them draw conclusions about the authenticity of ingredients or
raw materials. This stakeholder suggested that if an information
clearinghouse had existed prior to the heparin incident, it could have
contained critical information--such as the sudden increase or
decrease in the price of ingredients for food or drugs --to alert FDA
and industry to the potential for adulteration.
One stakeholder noted that because some of the industries affected by
economic adulteration are small, some companies might easily be
identified by the information reported, even if they reported it
anonymously. Consequently, some stakeholders suggested engaging a
neutral third party to operate the information clearinghouse, thus
helping to ensure that the information shared was free of specific
company identifiers. FDA officials said that they are examining
various ways to facilitate information sharing with industry and have
discussed the idea of a clearinghouse, but they have no plans to
develop one.
In addition to formal information sharing, some stakeholders suggested
more informal interaction between industry and FDA. Stakeholders noted
that increased dialogue could provide opportunities for FDA to
communicate to industry its overall strategy on economic adulteration.
Some stakeholders told us that FDA's communication during adverse
public health events was clear and timely but that at other times they
were unsure what FDA was doing to address potential economic
adulteration. Some stakeholders expressed a willingness to work with
FDA on the issue but said that they need to better understand FDA's
expectations of industry. For example, one stakeholder suggested a
forum where FDA officials can talk to industry directly and engage in
dialogue to clarify the agency's strategy.
Some stakeholders from food industry groups also said that they
believe the recent passage of the FDA Food Safety Modernization Act
provides new opportunities for both FDA and industry to address
economic adulteration. One stakeholder noted that the new law may give
FDA more opportunities to include economic adulteration in its
inspection program. In addition, stakeholders told us that they
believe the law provides a science-and risk-based approach for
companies to verify their ingredient suppliers, including multiple
ways of assuring the public and FDA that industry has processes in
place to detect economic adulteration. Specifically, under the act,
certain facilities are required to identify reasonably foreseeable
hazards and to prepare written control plans that illustrate
reasonable approaches to looking for intentional adulteration.
Lastly, one stakeholder said that FDA may need additional authority to
require the drug industry to provide the agency with information
critical to securing the medical product supply chain. Additional
authority may include, for example, allowing FDA to require enhanced
documentation from industry on its supply chains to increase
transparency. In its comments on one of our recent reports, HHS also
mentioned legislation previously under consideration by Congress that
it believed would, if enacted, provide FDA with helpful tools to
further secure the nation's drug supply chain.[Footnote 25] For
example, according to the agency, the proposed legislation would have
provided FDA authority to require foreign and domestic drug
manufacturers to implement quality systems and adopt plans to identify
and mitigate hazards. In its comment letter, FDA said that such
legislation could ensure that the agency can hold industry accountable
for the security and integrity of its supply chains and quality
control systems.
Conclusions:
Economic adulteration is not a new problem. It can undermine
confidence in the safety of the nation's food and medical products and
have significant economic consequences for industry. The recent crises
involving the contamination of pet food with melamine and the
adulteration of heparin with oversulfated chondroitin sulfate showed
that economic adulteration continues to be a problem and can have
serious public health consequences. Senior FDA officials, including
the Commissioner, have often spoken publicly about the threat posed by
economic adulteration. However, FDA does not have a definition of
economic adulteration. Without such a definition, when FDA detects
adulteration, it is more difficult for the agency to make a
distinction between economic adulteration and other forms of
adulteration to guide the agency's thinking about how to be more
proactive about this issue. In addition, FDA has not provided guidance
to its centers and offices on how they should approach or address
their economic adulteration efforts. This is not consistent with
federal standards of internal control, which state that agencies
should have documented policies and procedures in place to carry out
management's directives. Some entities have undertaken efforts that
specifically focus on economic adulteration, but they have not always
communicated or coordinated their efforts with other FDA entities.
Without such communication and coordination, in these times of
economic uncertainty, FDA may not be making the best use of its scarce
resources. As food and medical product supply chains become increasing
global and complex, economic adulteration will continue to remain a
threat.
Recommendations for Executive Action:
To enhance FDA's efforts to combat the economic adulteration of food
and medical products, we recommend that the Commissioner of FDA take
the following three actions:
* adopt a working definition of economic adulteration,
* provide written guidance to agency centers and offices on the means
of addressing economic adulteration, and:
* enhance communication and coordination of agency efforts on economic
adulteration.
Agency Comments and Our Evaluation:
We provided a draft of this report to HHS for review and comment. We
received written comments from HHS, which are reproduced in appendix
II. HHS neither agreed nor disagreed with our recommendations. In its
comments, HHS stated that FDA views the term "economically motivated
adulteration" as describing a subset of cases within the broader
concept of adulteration, and believes that a holistic approach toward
understanding and addressing adulteration generally is the best course
forward. HHS also said that this approach will best serve the agency
as it strives to protect the health and well-being of the American
people by preventing, detecting, and taking appropriate responses to
all adulterations of food and medical products. As we note in our
report, however, agency entities have missed opportunities to
communicate and coordinate efforts specifically directed at economic
adulteration and identify potential public health risks. At the same
time, FDA said that it recognizes the importance of sharing and
leveraging information relevant to economically motivated adulteration
and the utility of a mechanism for facilitating such sharing and
collaboration at FDA. The department provided additional information
in its written comments on planned actions of FDA's Working Group on
Economically Motivated Adulteration that are consistent with two of
the three recommendations we made in our draft report. The additional
comments related to our recommendations that FDA adopt a working
definition of economic adulteration and enhance communication and
coordination of agency efforts on economic adulteration are as follows:
* Adopt a working definition of economic adulteration. HHS stated that
the Working Group on Economically Motivated Adulteration will use the
working definition of economically motivated adulteration that FDA
proposed at its May 2009 public meeting on the topic.
* Enhance communication and coordination of agency efforts on economic
adulteration. HHS stated that FDA expects the efforts of the working
group will result in enhanced collaboration and communication at FDA
on ways to approach and address situations of economically motivated
adulteration.
We have included this additional information in our report.
HHS also provided technical comments, which we incorporated as
appropriate.
As agreed with your offices, unless you publicly announce the contents
of this report earlier, we plan no further distribution until 30 days
from the report date. At that time, we will send copies of this report
to the appropriate congressional committees, the Secretary of Health
and Human Services, the Commissioner of the Food and Drug
Administration, and other interested parties. In addition, the report
will be available at no charge on the GAO website at [hyperlink,
http://www.gao.gov].
If you or your staffs have any questions about this report, please
contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov or Marcia
Crosse at (202) 512-7114 or crossem@gao.gov. Contact points for our
Offices of Congressional Relations and Public Affairs may be found on
the last page of this report. GAO staff who made key contributions to
this report are listed in appendix III.
Signed by:
Lisa Shames:
Director, Natural Resources and Environment:
Signed by:
Marcia Crosse:
Director, Health Care:
[End of section]
Appendix I: Objectives, Scope, and Methodology:
This report examines (1) the approaches the Food and Drug
Administration (FDA) uses to detect and prevent economic adulteration
of food and medical products, and (2) the challenges, if any, FDA
faces in detecting and preventing economic adulteration and
stakeholder views on options for FDA to enhance its efforts to address
economic adulteration. For this report, we define economic
adulteration as "the fraudulent, intentional substitution or addition
of a substance in a product for the purpose of increasing the apparent
value of the product or reducing the cost of its production, i.e., for
economic gain. [It] includes dilution of products with increased
quantities of an already-present substance (e.g., increasing inactive
ingredients of a drug with a resulting reduction in strength of the
finished product, or watering down of juice) to the extent that such
dilution poses a known or possible health risk to consumers, as well
as the addition or substitution of substances in order to mask
dilution." Our definition of economic adulteration is the same as the
working definition of "economically motivated adulteration" that FDA
developed for a May 2009 public meeting to raise awareness and solicit
input on the topic. We did not include counterfeiting of a finished
product because counterfeiting concerns the unauthorized use of
intellectual property rights.
To determine the approaches FDA uses to detect and prevent economic
adulteration of food and medical products, we interviewed officials
from the five FDA centers responsible for food and medical products,
including the Center for Food Safety and Applied Nutrition, the Center
for Veterinary Medicine, the Center for Drug Evaluation and Research,
the Center for Devices and Radiological Health, and the Center for
Biologics Evaluation and Research, as well as FDA's Office of
Regulatory Affairs, Office of International Programs, and Office of
the Commissioner. We also interviewed former FDA officials and
representatives of organizations that have been assisting FDA in its
efforts to detect and prevent economic adulteration, including the
United States Pharmacopeia, the University of Minnesota's National
Center for Food Protection and Defense, and New Mexico State
University's Center for Animal Health, Food Safety and Bio-Security.
We reviewed relevant FDA documents, including regulations, compliance
manuals and inspection guides, sampling surveillance results,
statements and presentations by agency officials, a contract to fund a
research project at the National Center for Food Protection and
Defense, and communications with industry and the public. We also
reviewed published information from FDA, including its Strategic
Priorities 2011-2015 report, its Pathway to Global Product Safety and
Quality report, and Federal Register notices. We also reviewed
previous GAO reports and recommendations on FDA's oversight of food
and medical products, as well as the agency's strategic planning
efforts. We compared FDA's efforts to address economic adulteration
with federal standards for internal control.[Footnote 26]
To determine the challenges FDA faces in detecting and preventing
economic adulteration, we interviewed and obtained the views of FDA
officials and stakeholders about the challenges the agency faces in
addressing economic adulteration. Stakeholders included members of
academia and representatives of industry and consumer groups who made
presentations at FDA's May 2009 meeting on economically motivated
adulteration, as well as former FDA officials who were involved in
agency efforts that led to that meeting. We also interviewed and
obtained the views of the stakeholders on options for FDA to enhance
its efforts to address economic adulteration. The views of these
stakeholders are not representative of and cannot be generalized to
all stakeholders. In addition, we reviewed FDA and stakeholder
documents related to challenges and options, as well as portions of
the FDA Food Safety Modernization Act.
We conducted this performance audit from September 2010 to October
2011 in accordance with generally accepted government auditing
standards. Those standards require that we plan and perform the audit
to obtain sufficient, appropriate evidence to provide a reasonable
basis for our findings and conclusions based on our audit objectives.
We believe that the evidence obtained provides a reasonable basis for
our findings and conclusions based on our audit objectives.
[End of section]
Appendix II: Comments from the Department of Health and Human Services:
Department Of Health & Human Services:
Office Of The Secretary:
Assistant Secretary for Legislation:
Washington, DC 20201:
October 7, 2011:
Lisa Shames, Director:
Natural Resources and Environment:
U.S. Government Accountability Office:
441 G Street NW:
Washington, DC 20548:
Dear Ms. Shames:
Attached are comments on the U.S. Government Accountability Office's
(GAO) draft report entitled, "Food And Drug Administration: Better
Coordination Could Enhance Efforts to Address Economic Adulteration
and Protect the Public Health" (GAO-12-46).
The Department appreciates the opportunity to review this report
before its publication.
Sincerely,
Signed by:
Jim R. Esquea:
Assistant Secretary for Legislation:
Attachment:
cc: Marcia Crosse, Director, Health Care:
[End of letter]
General Comments Of The Department Of Health And Human Services (HHS)
On The Government Accountability Office's (GAO) Draft Report Entitled,
"Food And Drug Administration: Better Coordination Could Enhance
Efforts To Address Economic Adulteration And Protect The Public
Health" (GAO-12-46):
The Department appreciates the opportunity to comment on this draft
report.
More and more of the foods and medical products that the Food and Drug
Administration (FDA) regulates are produced overseas, by hundreds of
thousands of firms, and the paths by which these products reach our
borders and travel on to our grocery stores, hospitals, pharmacies and
doctors' offices are increasingly long and complex. The global nature
of the U.S. marketplace presents formidable challenges to the FDA as
it works to ensure the safety of these foods and medical products. The
sheer number of firms and complexity of these supply chains provide
myriad opportunities for many forms of adulteration, any of which
poses risk to the health and well-being of the American people. For
example, FDA has grappled with adulteration of food and medical
products arising from deficient manufacturing practices, including
insufficient attention to the sources and supply chains for
ingredients; cargo theft; counterfeiting; and apparent economic
motivation. It is also conceivable that FDA-regulated products could
be used as a vehicle for terrorists.
FDA's first priority is to protect the American public by enhancing
its capacity to prevent, detect, and respond to all adulterations that
may harm American consumers and patients. The adulteration of pet food
with melamine, and heparin with oversulfated chondroitin sulfate,
serve as compelling illustrations of the challenges that FDA faces in
securing our food and pharmaceutical supply chains. These incidents
demonstrate the increasing opportunities that extended and fractured
supply chains present to those who, for economic gain or to
intentionally harm people, are willing to adulterate foods and drugs.
The melamine and heparin contamination incidents are not the first
such examples, and they may not be the last. They are clarion calls to
the agency, and anyone with an interest in promoting the public
health, to improve controls on quality in, and collect better
information about, the supply chains of products, and to develop tools
for anticipating, preventing, and taking actions to address the
adulteration. These iconic incidents have served to heighten the
efforts across the FDA to address these challenges.
FDA views the term "economically motivated adulteration," as
describing a subset of cases within the broader concept of
adulteration, and believes that a holistic approach toward
understanding and addressing adulteration generally is the best course
forward. Securing the supply chains of FDA-regulated goods will help
the agency to minimize opportunities for contamination and
adulteration--whether intentional or otherwise. In terms of motivation
or intention, often it is the ignorance, indifference or recklessness
of someone downstream in the supply chain that provides opportunities
for intentional adulteration by someone up-stream. Only a holistic,
quality systems approach toward securing these supply chains will
effectively constrain opportunities for adulteration, regardless of
motivation. In addition, the agency believes that in responding to
instances of adulteration, its first focus must be to identify the
adulterated product and remove it from the supply chain so that it is
not circulating in the market place where it can harm consumers or
patients, regardless of the reason or motivation for the adulteration.
Prompted by the ever-changing and unpredictable global environment
that threatens the safety of pharmaceutical and food supply chains,
FDA has developed a strategy, articulated in FDA's Pathway to Global
Product Safety and Quality, that fundamentally changes its posture
from intercepting adulterated product to anticipating and preventing
conditions and actions that could threaten the health and safety of
the American people. Although this particular GAO study focuses
specifically on what it calls "economic adulteration," and GAO would
have the agency focus on discerning whether adulteration is economic
or not, FDA emphasizes its strategy to address the increasingly
complex and unpredictable global environment through a holistic
approach that recognizes and adapts to the broad challenges of
globalization and the numerous opportunities it provides for all forms
of adulteration. As explained in the Pathway to Global Product Safety
and Quality, FDA's approach is to transform itself fully into a global
regulatory agency with an "international operating model that relies
on enhanced intelligence, information sharing, data-driven risk
analytics, and the smart allocation of resources through leveraged
partnerships." This approach will best serve the agency as it strives
to protect the health and well-being of the American people by
preventing, detecting, and taking appropriate responses to all
adulterations of food and medical products.[Footnote 1]
The Food Safety Modernization Act of 2011 (FSMA) charged FDA with
building a modern, prevention-oriented food safety system suited for
today's globalized food supply. Specifically, FSMA provided FDA with
new authority to promulgate a wide range of regulations, with an
enhanced focus on risk-based resource allocation, and partnership
across the public and private sectors to minimize hazards from farm-to-
table. Many of FDA's new authorities under FSMA enhance FDA's ability
to prevent adulteration, including economically motivated
adulteration. These authorities include requirements for a system of
hazard analysis and risk-based preventive controls in most food
facilities, new standards for produce safety, mandatory recall
authority, administrative detention, requirements to specifically
protect against the intentional adulteration of high-risk foods,
enhanced tracking and tracing of food and new recordkeeping
requirements, enhanced authority to inspect foreign food facilities,
and the development of a foreign supplier verification program.
Similarly, obtaining new drug safety regulatory authorities directed
toward an increasingly complex and globalized world may help ensure
the security and integrity of drug supply chains and the systems used
to produce pharmaceutical products for the American people. Such new
authorities, if enacted, could help to level the playing field between
domestic and foreign drug manufacturers, ensure drug product safety,
and provide FDA with the information it needs to protect consumers.
Those authorities may include:
* Refusal of drug product admission to the United States if inspection
of the manufacturing facility is delayed, limited, or denied;
* Requirement of information or other assurance of compliance with
applicable standards or requirements as a condition of importation;
* Quality management systems to place greater responsibility on
manufacturers to account for the quality and provenance of the
materials that go into their products;
* Mandatory recall authority;
* Administrative destruction at the border;
* Administrative detention;
* Enhanced criminal and civil penalties for foreign and domestic
suppliers;
* Modernization of drug registration and listing;
* Notification to FDA from foreign and domestic companies of complete
information on threats such as counterfeiting, theft, non-compliance
with regulatory standards, mislabeling or misbranding, or other
threats to the security of the drug supply chain;
* Unique facility identifiers as a condition of registration and
importation to help FDA to follow threats up the supply chain and to
properly cross-reference;
* Authority to share certain non-public information with other
regulatory agencies and foreign governments in order to allow FDA to
share certain information that could lead to timely identification,
prevention, and resolution of emerging threats; and;
* The requirement of a cost-effective track-and-trace system for all
drug products throughout the supply chain to improve the security and
integrity of the drug supply and ensure transparency and
accountability of product manufacturing and distribution, whether the
product is manufactured domestically or internationally.
Within this broad strategic framework to address the challenges of
globalization, FDA recognizes the importance of sharing and leveraging
information relevant to economically motivated adulteration and the
utility of a mechanism for facilitating such sharing and collaboration
at FDA. To that end, FDA recently established the Working Group on
Economically Motivated Adulteration (WEMA). Comprised of staff from
all of the Centers, ORA, and Office of the Commissioner, including
risk managers, economists, regulatory counsel, and policy analysts,
WEMA seeks to encourage information sharing across FDA on issues
relevant to economically motivated adulteration. Because such threats
have common risk factors, FDA can benefit from sharing intelligence,
experiences, data, models, and strategies. This collaboration may
include the development of approaches to prevent economically
motivated adulteration and processes for information sharing.
To identify topics of broad FDA interest, the WEMA will use the
working definition proposed at the May 1, 2009 Public Meeting on
economically motivated adulteration:
The fraudulent, intentional substitution or addition of a substance in
a product for the purpose of increasing the apparent value of the
product or reducing the cost of its production, i.e., for economic
gain. EMA includes dilution of products with increased quantities of
an already-present substance (e.g., increasing inactive ingredients of
a drug with a resulting reduction in strength of the finished product,
or watering down of juice) to the extent that such dilution poses a
known or possible health risk to consumers, as well as the addition or
substitution of substances in order to mask dilution.
This working definition has been used to generate dialogue between the
FDA, the regulated community, and advocacy groups. It has gained
traction as a practical working definition, and although it does not
serve as a legal definition or require conformance or uniform
acceptance, it is a functional and adaptable means of identifying
situations of economically motivated adulteration that may concern
multiple Centers, enabling them to focus their discussions and
encouraging communication and collaboration.
Organized by the Office of Regulatory Affairs' Risk Management Staff,
the WEMA held its first meeting on September 23, 2011, with plans to
meet regularly to accomplish its goals. The WEMA will facilitate
discussion and recommendations on the exchange of information and
intelligence related to economically motivated adulteration. FDA
expects that the work group's efforts will result in enhanced
collaboration and communication at FDA on ways to approach and address
these important public health issues.
Appendix II Footnote:
[1] In addition, in September 2011 FDA issued for comment a draft FDA
Foods and Veterinary Medicine Program Strategic Plan for 2012-2016.
The draft Strategic Plan identifies "intentional contamination" as a
growing concern in the food and veterinary medicine program areas and
indicates that key initiatives in coming years include setting
preventive control standards for intentional contamination.
[End of section]
Appendix III: GAO Contacts and Staff Acknowledgments:
GAO Contacts:
Lisa Shames at (202) 512-3841 or shamesl@gao.gov:
Marcia Crosse at (202) 512-7114 or crossem@gao.gov:
Staff Acknowledgments:
In addition to the contacts named above, Jose Alfredo Gomez (Assistant
Director), Geraldine Redican-Bigott (Assistant Director), Cheryl
Williams (Assistant Director), Kevin Bray, Mollie Hertel, Sherrice
Kerns, Susan Malone, Michael Rose, Cynthia Saunders, Ben Shouse, and
Kiki Theodoropoulos made key contributions to this report.
[End of section]
Related GAO Products:
High-Risk Series:
High-Risk Series: An Update. [hyperlink,
http://www.gao.gov/products/GAO-11-278]. Washington, D.C.: February
2011.
Reports and Testimonies:
Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug
Manufacturing Supply Chain. [hyperlink,
http://www.gao.gov/products/GAO-11-936T]. Washington, D.C.: Sept. 14,
2011.
Medical Devices: FDA Should Enhance Its Oversight of Recalls.
[hyperlink, http://www.gao.gov/products/GAO-11-468]. Washington, D.C.:
June 14, 2011.
Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and
Better Leverage Limited Resources. [hyperlink,
http://www.gao.gov/products/GAO-11-286]. Washington, D.C.: April 14,
2011.
Federal Food Safety Oversight: Food Safety Working Group Is a Positive
First Step but Governmentwide Planning Is Needed to Address
Fragmentation. [hyperlink, http://www.gao.gov/products/GAO-11-289].
Washington, D.C.: March 18, 2011.
Food Labeling: FDA Needs to Reassess Its Approach to Protecting
Consumers from False or Misleading Claims. [hyperlink,
http://www.gao.gov/products/GAO-11-102]. Washington, D.C.: January 14,
2011.
Food and Drug Administration: Response to Heparin Contamination Helped
Protect Public Health; Controls That Were Needed for Working With
External Entities Were Recently Added. [hyperlink,
http://www.gao.gov/products/GAO-11-95]. Washington, D.C.: October 29,
2010.
Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to
Improve Its Information on Foreign Establishments, but More Progress
Is Needed. [hyperlink, http://www.gao.gov/products/GAO-10-961].
Washington, D.C.: September 30, 2010.
Food and Drug Administration: Overseas Offices Have Taken Steps to
Help Ensure Import Safety, but More Long-Term Planning Is Needed.
[hyperlink, http://www.gao.gov/products/GAO-10-960]. Washington, D.C.:
September 30, 2010.
Food Safety: FDA Could Strengthen Oversight of Imported Food by
Improving Enforcement and Seeking Additional Authorities. [hyperlink,
http://www.gao.gov/products/GAO-10-699T]. Washington, D.C.: May 6,
2010.
Food and Drug Administration: Opportunities Exist to Better Address
Management Challenges. [hyperlink,
http://www.gao.gov/products/GAO-10-279]. Washington, D.C.: February
19, 2010.
Food Safety: Agencies Need to Address Gaps in Enforcement and
Collaboration to Enhance Safety of Imported Food. [hyperlink,
http://www.gao.gov/products/GAO-09-873]. Washington, D.C.: September
15, 2009.
Food and Drug Administration: FDA Faces Challenges Meeting Its Growing
Medical Products Responsibilities and Should Develop Complete
Estimates of Its Resource Needs. [hyperlink,
http://www.gao.gov/products/GAO-09-581]. Washington, D.C.: June 19,
2009.
Seafood Fraud: FDA Program Changes and Better Collaboration among Key
Federal Agencies Could Improve Detection and Prevention. [hyperlink,
http://www.gao.gov/products/GAO-09-258]. Washington, D.C.: February
19, 2009.
Dietary Supplements: FDA Should Take Further Actions to Improve
Oversight and Consumer Understanding. [hyperlink,
http://www.gao.gov/products/GAO-09-250]. Washington, D.C.: January 29,
2009.
[End of section]
Footnotes:
[1] According to FDA officials, the imported vegetable protein
products also contained cyanuric acid, a melamine-related compound.
Melamine and cyanuric acid individually are relatively nontoxic.
However, when combined, they produce crystals, which can lead to
kidney failure. For purposes of this report, we use the term melamine
to mean melamine and its related analogs (e.g., melamine and cyanuric
acid).
[2] Biologics are generally materials--such as vaccines--derived from
living sources, such as humans, animals, and microorganisms, as well
as materials produced by biotechnology methods. See 42 U.S.C. §
262(i); 21 C.F.R. § 600.3(h).
[3] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: February
2011).
[4] GAO, High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January
2007); and High-Risk Series: An Update, [hyperlink,
http://www.gao.gov/products/GAO-09-271] (Washington, D.C.: January
2009).
[5] See 74 Fed. Reg. 15498 (Apr. 6, 2009).
[6] For the purposes of this report, we are using the term "economic
adulteration" to mean "economically motivated adulteration."
[7] The United States Department of Agriculture is responsible for
ensuring the safety of meat and poultry products.
[8] According to FDA's Office of Chief Counsel, formal enforcement
actions available to FDA include initiating a seizure of an
adulterated product, seeking an injunction to stop a company from
engaging in certain behavior, or referring a firm for criminal
prosecution. FDA can also issue warning letters, which are intended to
prompt companies to voluntarily correct violations of regulatory
significance.
[9] GAO, Food and Drug Administration: FDA Faces Challenges Meeting
Its Growing Medical Product Responsibilities and Should Develop
Complete Estimates of Its Resource Needs, [hyperlink,
http://www.gao.gov/products/GAO-09-581] (Washington, D.C.: June 19,
2009).
[10] GAO, Food and Drug Administration: Opportunities Exist to Better
Address Management Challenges, [hyperlink,
http://www.gao.gov/products/GAO-10-279] (Washington, D.C.: Feb. 19,
2010).
[11] GAO, Food and Drug Administration: Overseas Offices Have Taken
Steps to Help Ensure Import Safety, but More Long-Term Planning Is
Needed, [hyperlink, http://www.gao.gov/products/GAO-10-960]
(Washington, D.C.: Sept. 30, 2010).
[12] The official drug compendium of the United States is the United
States Pharmacopeia/National Formulary, published by the United States
Pharmacopeial Convention, a non-governmental, standard-setting
authority.
[13] For more information on PREDICT, see Food Safety: FDA Has Begun
to Take Action to Address Weaknesses in Food Safety Research, but Gaps
Remain, [hyperlink, http://www.gao.gov/products/GAO-10-182R]
(Washington, D.C.: Apr. 23, 2010).
[14] API refers to any component that is intended to provide
pharmacological activity or other direct effect in the diagnosis,
cure, mitigation, treatment, or prevention of disease.
[15] These standards are in the form of monographs--written standards
that describe a substance or product, including information on tests
needed to ensure that the substance is of the appropriate strength,
quality, and purity.
[16] The National Center for Food Protection and Defense is a research
consortium that addresses the vulnerability of the nation's food
system to attack through intentional contamination with biological or
chemical agents.
[17] While CVM has not undertaken any efforts exclusively targeting
economic adulteration, in its written comments on our draft report,
HHS noted that CVM is participating in an FDA Monograph Modernization
Task Group to help USP prioritize monographs in need of modernization,
which includes reduction of economic adulteration.
[18] [hyperlink, http://www.gao.gov/products/GAO-10-279].
[19] Department of Health and Human Services, U.S. Food and Drug
Administration, Pathway to Global Product Safety and Quality
(Washington, D.C.: July 2011).
[20] GAO, Standards for Internal Control in the Federal Government,
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1]
(Washington, D.C.: November 1999).
[21] GAO, Medical Devices: Shortcomings in FDA's Premarket Review,
Postmarket Surveillance, and Inspections of Device Manufacturing
Establishments, [hyperlink, http://www.gao.gov/products/GAO-09-370T]
(Washington, D.C.: June 18, 2009).
[22] [hyperlink, http://www.gao.gov/products/GAO-09-581], and GAO,
Food and Drug Administration: Effect of User Fees on Drug Approval
Times, Withdrawals, and Other Agency Activities, [hyperlink,
http://www.gao.gov/products/GAO-02-958] (Washington, D.C.: Sept. 17,
2002).
[23] GAO, Medical Devices: FDA Should Enhance Its Oversight of
Recalls, [hyperlink, http://www.gao.gov/products/GAO-11-468]
(Washington, D.C.: June 14, 2011).
[24] GAO, Seafood Fraud: FDA Program Changes and Better Collaboration
among Key Federal Agencies Could Improve Prevention and Detection,
[hyperlink, http://www.gao.gov/products/GAO-09-258] (Washington, D.C.:
Feb. 19, 2009).
[25] [hyperlink, http://www.gao.gov/products/GAO-11-95].
[26] GAO, Standards for Internal Control in the Federal Government,
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1]
(Washington, D.C.: November 1999).
[End of section]
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